DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 08/21/2025 has been entered.
Priority
This application claims priority from PCT/CA2013/000163, International Filing Date: 02/25/2013.
Status of Claims
Claims 1-13 and 15-17 are pending.
Claims 14 and 18-19 have been cancelled.
Election/Restrictions
Applicant elected Species 3 (Figure 5), Sub-Species A (Rapid exchange for main lumen), and Sub-Species A (Rapid exchange for branch lumen) on 05/29/2024 without traverse.
Drawings
The drawing objections have been withdrawn in response to the applicant’s amendments.
Claim Rejections - 35 USC § 112
The 112 rejections have been withdrawn in response to the applicant’s amendments.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-7, 10-13, and 15-17 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Webster US 6,096,073 in view of Shaknovich US 5,669,924 and Weikel US 2002/0177866 A1.
Webster discloses the invention substantially as claimed being an inflatable apparatus 50 for use in a bifurcated vessel (Figures 10A-D) having a main branch 14 from which a side branch 16 extends at an angle therefrom, comprising:
a first balloon 54 having proximal and distal ends (left and right sides Figures 8AB) and proximal and distal portions (left and right portions near the ends Figures 8AB);
a conduit 68 extending longitudinally through said first balloon from a first opening (left side Figures 8AB where conduits exit balloon) proximate the distal end of said first balloon to a second opening (upper opening in intermediate portion of balloon Figures 8AB) disposed between said proximal and distal ends of said first balloon; said first balloon being positionable within said main branch (Figures 10AB), said first balloon expands radially in said main branch.
Webster discloses the use of a guidewire positioned through the second opening of the first balloon. However, Webster does not disclose the use of a second balloon for expanding the second stent into the side branch or the use of a bend section on the balloon.
Shaknovich teaches the use of primary and secondary branch balloons (1a/1b Figure 1) simultaneously expandable (Figure 1) within the art of stent delivery to bifurcated implant sites is old and well known for the purpose of supporting dual stent structures throughout the surgery in adjacent branching vessels.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to eliminate the step of deflating and repositioning the balloon of Webster and to provide the second balloon taught by Shaknovich along the branch guidewire through the second opening of the first balloon of Webster in order to maintain support for both the main and size branches during implantation and to prevent movement or misalignment during the insertion of the second stent. Additionally this will eliminate the possibility of affecting the position of the first stent when withdrawing the first balloon.
The combination would result in a system with a second balloon (Shaknovich) arranged to be advanced along the second guidewire within the conduit of the first balloon (shown in Figures 10A-D of Webster) and then allowing for part of the second balloon to extend out of the first balloon and into the side branch during expansion of both balloons.
Weikel teaches the use of expandable balloons comprising two cylindrical segments (245 Figure 28) connected by pre-formed reverse bend sections (240 are considered reverse bends because they bend back towards the first cylindrical portion Figure 28) in the same field of endeavor for the purpose of permitting flexing without putting undue stress on the balloon and implant site.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to combine the cylindrical portions and angular bends of the balloons of Weikel with the balloons of the combination in order to better accommodate bending without putting undue stress on the balloon and implant site.
The combination would result in a universal bend allowing for reverse bends that permit the distal portion of the second cylindrical portion to remain parallel to the first balloon during insertion and conform to the angle of the side branch during inflation.
2. Webster discloses the second opening is located approximately midway between the proximal and distal ends of said first balloon (Figures 8AB of Webster).
3. Webster discloses the shape of the first balloon and the shape of the distal portion of said second balloon are selected based on predetermined shapes of the main and side branches, respectively (Figures 10A-D show these shapes matching the shapes of the branches).
4. The combination discloses the first and second balloons are inflatable concurrently (Figure 1 of Shaknovich).
5. The combination discloses the first and second balloons are inflatable separately (this is inherent because no structure prevents one balloon from being inflated before the other).
6. The combination discloses a catheter extending through each of said first and second balloons (Webster discloses the balloon comprises a catheter Figure 8A and Shaknovich discloses the balloons comprise catheters 220, extending from the balloons and containing the filling components).
7. Webster discloses the a guide wire system for each path of the balloon (36 and 38) for use in the positioning of the main branch balloon in the main branch of the vessel and the distal portion of the side branch balloon in the side branch of the vessel.
10. Webster discloses a first radially expandable stent 74 positioned on said first balloon (Figures 10A-D), wherein when said first balloon is inflated, said first stent radially expands within said main branch (Figures 10C-D but modified to include the second balloon of Shaknovich).
11. Webster discloses the first radially-expandable stent comprises a side opening 82 through which the distal end of said second balloon extends (Figures 10C-D but modified to include the second balloon of Shaknovich).
12. Webster discloses a second radially-expandable stent (96 Figures 10C-D) positionable on the distal end of said second balloon, wherein when said second balloon is inflated, said second stent radially expands within said side branch (Figures 10C-D but modified to include the second balloon of Shaknovich).
13. The combination discloses said second stent has a proximal and distal end and said proximal end is shaped to cooperate with said opening of said first stent upon expansion (the stent and opening both have matching circular cross-sections which cooperate Figures 10A-D).
15. The combination discloses the second balloon portion is extendable at an angle of between 10 degrees and 170 degrees from said first balloon when said balloons are inflated (Figures 10A-D show and angle of at least 45 degrees).
16 and 17. The claimed method of making the balloons amounts to a product by processes limitations. Whether a product is patentable depends on whether it is known in the art or it is obvious, and is not governed by whether the process by which it is made is patentable. Product by process claims are not construed as being limited to the product formed by the specific process recited. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process (see MPEP 2113). In this case the balloons of the combination are fully capable of being made from known blow molding and split mold processes.
Claims 8 and 9 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Webster, Shaknovich, and Weikel (Combination 1) as applied to claims 1-7, 10-13, and 15-17 above, and further in view of Fischell US 5,749,825.
Combination 1 discloses the invention substantially as claimed being described above. However, Combination 1 does not disclose the use of rapid exchange wire system.
Fischell teaches it is old and well known in the art of stent catheters to use rapid exchange catheters for the purpose of quicker loading and delivery times (5:19-30).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the catheter/guidewires of Combination 1 to include rapid exchange catheters/guidewires as disclosed by Fischell in order to provide quicker loading and delivery times.
Response to Arguments
Applicant's arguments filed 05/27/2025 have been fully considered but they are not persuasive.
The applicant argues that Webster does not disclose the positioning of the second balloon within the first balloon. This is not persuasive because Webster discloses all the structures except a second balloon. As explained above Webster discloses in Figure 10B a first balloon expanded in a main vessel with a side opening extending through the first balloon that a guidewire extends through and into the side branch. Shaknovich discloses the use of simultaneous first and second balloons inserted and expanded within main and side branches of the vessel. Therefore it would have been obvious to one of ordinary skill in the art to maintain the apparatus of Webster as shown in Figures 8AB and 10AB, but to provide the second balloon of Shaknovich along the second guidewire 38 through the first balloon second opening. This will ensure complete and full expansion of both stents while eliminating the chance of collapsing the previously nonexpanded branch. This also eliminates the possibility of shifting the first stent when deflating, withdrawing, and reinstalling the first balloon. Since Webster previously discloses the first balloon with the side opening and a second guidewire extending out a side opening, it would have been obvious to advance a second balloon over that guidewire through the side opening of the first balloon.
Additionally, the actual steps of inserting the balloons including the timing and positioning amount to intended use limitations and given limited weight. The claims are directed at the apparatus itself not the method of using the apparatus. As explained above it would have been obvious to one of ordinary skill in the art to insert a second balloon as claimed, but since the prior art discloses all the claimed elements which are capable of performing the applicant’s intended use, they inherently read upon the claimed use.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER D PRONE whose telephone number is (571)272-6085. The examiner can normally be reached Monday-Friday 10 am - 6 pm (HST).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie R Tyson can be reached on (571)272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Christopher D. Prone/Primary Examiner, Art Unit 3774